Risk assessment, defined

Assessment of the Risk to People. The first step in risk assessment defines the physical, chemical and pharmacological nature of the hazard. Considerations to be made may include ... 

Risk assessment iinoKes the integration of the information and analysis associated with the above four steps to provide a complete characterization of the nature and magnitude of risk and the degree of confidence associated with tliis characterization. A critical component of the assessment is a full elucidation of the uncertainties associated witli each of die major steps. Under this broad concept of risk assessment are encompassed all of the essential problems of toxicology. Risk assessment takes into account all of the available dose-response data. It should treat uncertainty not by the application of arbitrary safety factors, but by stating them in quantitatively and qualitatively explicit tenns, so tluit they tire not hidden from decision makers. Risk assessment defined in tliis broad way, forces an assessor to confront all the scientific uncertainties and to set fortli in e.xplicit terms tlie means used in specific cases to deal with these uncertainties. An e. panded presentation on each of the four hcaltli risk assessment steps is provided telow. 

Risk-Based Inspection. Inspection programs developed using risk analysis methods are becoming increasingly popular (15,16) (see Hazard ANALYSIS AND RISK ASSESSMENT). In this approach, the frequency and type of in-service inspection (IS I) is determined by the probabiUstic risk assessment (PRA) of the inspection results. Here, the results might be a false acceptance of a part that will fail as well as the false rejection of a part that will not fail. Whether a plant or a consumer product, false acceptance of a defective part could lead to catastrophic failure and considerable cost. Also, the false rejection of parts may lead to unjustified, and sometimes exorbitant, costs of operation (2). Risk is defined as follows ... 

A risk assessment analyses systems at two levels. The first level defines the functions the system must perform to respond successfully to an accident. The second level identifies the hardware for the systems use. The hardware identification (in the top event statement) describes minimum system operability and system boundaries (interfaces). Experience shows that the interfaces between a frontline system and its support systems are important to the system cs aluaiion and require a formal search to document the interactions. Such is facilitated by a failure modes and effect analysis (FMEA). Table S.4.4-2 is an example of an interaction FMEA for the interlace and support requirements for system operation. 

Risk assessment has usually been divided into four different and well-defined phases to ensure that all important issues will be given a fair consideration. The phases of systematic risk assessment include ... 

Risk is often defined as the likelihood of a certain event times a measure of the severity of its consequences. Most risk assessment studies concentrate on estimating the likelihood of certain events. They often concern the release of chemicals, or accidents in engineering projects and the project outcome. In thi.s section, the subject of accidents is not covered. Risk assessment (RA), as a technique, has been adopted by various national governments, by EU, and by OECD.-... 

Most human or environmental healtli hazards can be evaluated by dissecting tlie analysis into four parts liazard identification, dose-response assessment or hazard assessment, exposure assessment, and risk characterization. For some perceived healtli liazards, tlie risk assessment might stop with tlie first step, liazard identification, if no adverse effect is identified or if an agency elects to take regulatory action witliout furtlier analysis. Regarding liazard identification, a hazard is defined as a toxic agent or a set of conditions that luis the potential to cause adverse effects to hmnan health or tlie environment. Healtli hazard identification involves an evaluation of various forms of information in order to identify the different liaz.ards. Dose-response or toxicity assessment is required in an overall assessment responses/cffects can vary widely since all chemicals and contaminants vary in their capacity to cause adverse effects. This step frequently requires that assumptions be made to relate... 

Since 1970 tlie field of healtli risk assessment Itas received widespread attention witliin both tlie scientific and regulatoiy committees. It has also attracted tlie attention of the public. Properly conducted risk assessments have received fairly broad acceptance, in part because they put into perspective the terms to. ic, Itazard, and risk. Toxicity is an inlierent property of all substances. It states tliat all chemical and physical agents can produce adverse healtli effects at some dose or under specific exposure conditions. In contrast, exposure to a chemical tliat lias tlie capacity to produce a particular type of adverse effect, represents a health hazard. Risk, however, is tlie probability or likelihood tliat an adverse outcome will occur in a person or a group tliat is exposed to a particular concentration or dose of the hazardous agent. Tlierefore, risk can be generally a function of exposure and dose. Consequently, healtli risk assessment is defined as tlie process or procedure used to estimate tlie likelihood that... 

An appropriate sampling program is critical in the conduct of a hcaltli risk assessment. This topic could arguably be part of the exposure assessment, but it has been placed within hazard identification because, if the degree of contamination is small, no further work may be necessary. Not only is it important that samples be collected in a random or representative manner, but the number of samples must be sufficient to conduct a statistically valid analysis. The number needed to insure statistical validity will be dictated by the variability between the results. The larger the variance, tlic greater the number of samples needed to define tire problem, ... 

Health risk assessment is defined as Uie process or procedure used to estimate Uie likelihood that humans or ecological systems will be adversely affected by a chemical or physical agent under a specific set of conditions. 

Exposure is defined as llie contact of an organism (hmnans in llie case of health risk assessment) with a chemical or physical agent (3). 

Tlie reader should also note that tlie risk to people can be defined in terms of injury or fatality. The use of injuries as a basis of risk evaluation may be less disturbing tlian tlie use of fatalities. However, tliis introduces problems associated with degree of injury and comparability between different types of injuries. Further complications am arise in a risk assessment when dealing witli multiple hazards. For example, how are second-degree bums, fragment injuries, and injuries due to toxic gas e.xposure combined Even where only one type of effect (e.g., tlueshold to.xic exposure) is being evaluated, different durations of e.xposure can markedly affect tlie severity of injury. 

Tlie following simplified example, constructed by Hendershot, will facilitate tlie transition to tlie case studies. Suppose tliat a risk assessment is being conducted at a chemical plant to detenuine the consequences of two incidents (tlie initiating events of die event tree shown in Fig. 21.1.1) defined as... 

A biomarker is here defined as a biological response to an environmental chemical at the individual level or below, which demonstrates a departure from normality. Responses at higher levels of biological organization are not, according to this definition, termed biomarkers. Where such biological responses can be readily measnred, they may provide the basis for biomarker assays, which can be nsed to stndy the effects of chemicals in the laboratory or, most importantly, in the field. There is also interest in their employment as tools for the environmental risk assessment of chemicals. 

Apart from the use of this approach to study the ecotoxicology of neurotoxic pollutants in the field, it also has potential for use during the course of environmental risk assessment. An understanding of the relationship between biomarker responses to neurotoxic compounds and effects at the population level can be gained from both field studies and the use of mesocosms and other model systems. From these it may be possible to define critical thresholds in biomarker responses of indicator species above which population effects begin to appear. In the longer term, this approach... 

The major technical problem was the inability to define subsurface geohydrologic conditions with the initial data. Expertise in the area of geohydrology was clearly needed. A lack of specific analytical techniques precluded meaningful environmental and risk assessments. Cleanup efforts were complicated because poltiners are not regulated under RCRA but are regulated under state law. In the middle of the cleanup effort, the site became involved in Superfund activities, and to date this involvement has not been clarified. Project management has become very difficult because of the many players and laws involved. As a result, public confidence has been affected. 

Today, when a pesticide with no detectable residues is registered for use, a Tolerance or maximum residue limit (MRL) is established at the lowest concentration level at which the method was validated. However, for risk assessment purposes it would be wrong to use this number in calculating the risk posed to humans by exposure to the pesticide from the consumption of the food product. This would be assuming that the amount of the pesticide present in all food products treated with the pesticide and for which no detectable residues were found is just less than the lowest level of method validation (LLMV). The assumption is wrong, but there is no better way of performing a risk assessment calculation unless the limit of detection (LOD) and limit of quantification (LOQ) of the method were clearly defined in a uniformly acceptable manner. 

The simplest and most appropriate way to evaluate uncertainty is by using sensitivity analysis on the risk assessments. Sensitivity to a parameter is defined as the change in risk measure per unit change in that parameter (Ref. 76). 

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